CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3

K970976 · Medical Analysis Systems, Inc. · JJY · Apr 2, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970976
• Device Name: CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Medical Analysis Systems CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3 are ready-to-use liquid stable assayed control sera suitable for monitoring test procedures used in cardiac marker determinations.

Device Story

CARDIOIMMUNE Cardiac Marker Control (Levels 1, 2, 3) functions as an assayed quality control material for clinical laboratory cardiac marker testing. Product consists of human serum matrix supplemented with cardiac marker constituents, preservatives, and stabilizers. Liquid-stable formulation designed to minimize vial-to-vial variability. Used by laboratory personnel to monitor test procedure performance, ensuring consistency in day-to-day analytical results. Product requires storage at -20°C (unopened) or 2-8°C (opened/unopened) to maintain integrity.

Clinical Evidence

No clinical data; bench testing only. Product is an assayed control material; performance is established via analytical verification of constituent stability and consistency.

Technological Characteristics

Ready-to-use liquid stable assayed control sera. Matrix: human serum with added constituents, preservatives, and stabilizers. Storage: -20°C (unopened, 36 months), 2-8°C (unopened, 60 days; opened, 30 days).

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision and accuracy of laboratory test procedures for cardiac marker determinations in human serum.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Liquichek Cardiac Markers Control (K961828)

Submission Summary (Full Text)

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APR - 2 1997

Medical Analysis Systems, Inc.
Lincoln Technology Park • 542 Flynn Road • Camarillo, CA 93012-8058
Telephone: [phone] • FAX: [phone]

K970976

MEDICAL ANALYSIS SYSTEMS, INC.

510(k) Notification • March 14,1997
CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3

## 510(k) SUBMISSION

## Summary:

CARDIOIMMUNE Cardiac Marker Control, is substantially equivalent to the existing Liquichek™ Cardiac Markers Control, (K961828) currently in commercial distribution by BIO-RAD.

Medical Analysis Systems CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3 are ready-to-use liquid stable assayed control sera suitable for monitoring test procedures used in cardiac marker determinations. The controls are prepared from a human serum matrix with the addition of various constituents. Preservatives and stabilizers are added to maintain product integrity. The liquid matrix eliminates causes of vial to vial variability and, when handled as directed, provides consistency in day-to-day testing.

The controls are stable for 36 months from date of manufacture when stored unopened at -20°C. Unopened vials are stable for 60 days when stored at 2 - 8°C. Opened vials of control are stable for 30 days when stored tightly capped at 2 - 8°C.

Product Code: 75JJT

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